Archive | Regulatory

Bempegaldesleukin Plus Nivolumab Granted Breakthrough Designation in Melanoma by the FDA

The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.

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Posted in Melanoma News, Regulatory, Publications

FDA Approval in TGCT, Breakthrough Designation in Melanoma, and More

An FDA approval in tenosynovial giant cell tumor, a breakthrough therapy designation in melanoma, and encouraging findings in trials in bladder cancer, lung cancer, and a cell-free DNA assay.

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Posted in Melanoma News, Regulatory, Publications

FDA Will Review Application Seeking Expansion of Keytruda’s Dosing Schedule

The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.

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Posted in Melanoma News, Patients, Regulatory, Latest News, Publications

FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

Source: OncLive, July 2019 The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical […]

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Posted in Melanoma News, Regulatory, Publications